Table 2 Results of validation parameters
Parameter | Results | ICH limits | ||
|---|---|---|---|---|
DPF | 5-BC | 4-BC | ||
Retention time | 7.389 min | 7.952 min | 17.142 min | – |
System suitability | ||||
% RSD | 1.0 | 1.1 | 1.5 | NMT 2.0 |
Theoretical plates | 53,695 | 53,031 | 66,564 | > 2000 |
Tailing factor | 1.29 | 1.14 | 0.98 | NMT 2.0 |
Linearity | 50–150% | 0.01–0.225 | 0.03–0.225 | – |
% recovery | 98.6–101.2 | 100.1–102.8 | 100.1–102.8 | 98–103% |
System precision (% RSD) | 0.4 | 1.26 | 1.49 | NMT 2.0 |
Method precision (% RSD) | 0.4 | 0.82 | 0.71 | NMT 2.0 |
LOD (ppm) | 0.0000627 | 0.0000165 | 0.000053 | – |
LOQ (ppm) | 0.00019 | 0.00005 | 0.00016 | – |